Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count boxes distributed nationwide. The recall affects 49 cartons containing 6 vials each due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during storage or handling. The manufacturer, US WorldMeds, Inc., was unable to identify specific lot numbers for particular customers, but McKesson provided distribution dates to affected consignees to help identify potentially impacted product that may have been shipped during specific timeframes.
The recall notice does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 49 cartons/6 vials each Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.